Update of systemic immunotherapy for advanced urothelial carcinoma

von der Maase, 2005, Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer, J Clin Oncol, 23, 4602, 10.1200/JCO.2005.07.757 Galsky, 2011, Treatment of patients with metastatic urothelial cancer unfit for cisplatin-based chemotherapy, J Clin Oncol, 29, 2432, 10.1200/JCO.2011.34.8433 De Santis, 2012, Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: EORTC study 30986, J Clin Oncol, 30, 191, 10.1200/JCO.2011.37.3571 Bellmunt, 2009, Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract, J Clin Oncol, 27, 4454, 10.1200/JCO.2008.20.5534 McCaffrey, 1997, Phase II trial of docetaxel in patients with advanced or metastatic transitional-cell carcinoma, J Clin Oncol, 15, 1853, 10.1200/JCO.1997.15.5.1853 Roth, 1994, Significant activity of paclitaxel in advanced transitional-cell carcinoma of the urothelium: a phase II trial of the Eastern Cooperative Oncology Group, J Clin Oncol, 12, 2264, 10.1200/JCO.1994.12.11.2264 Sonpavde, 2017, PD-1 and PD-L1 inhibitors as salvage therapy for urothelial carcinoma, N Engl J Med, 376, 1073, 10.1056/NEJMe1701182 Lamm, 1991, A randomized trial of intravesical doxorubicin and immunotherapy with bacille Calmette-Guerin for transitional-cell carcinoma of the bladder, N Engl J Med, 325, 1205, 10.1056/NEJM199110243251703 Sharma, 2007, CD8 tumor-infiltrating lymphocytes are predictive of survival in muscle-invasive urothelial carcinoma, Proc Natl Acad Sci U S A, 104, 3967, 10.1073/pnas.0611618104 Poschke, 2011, Camouflage and sabotage: tumor escape from the immune system, Cancer Immunol Immunother, 60, 1161, 10.1007/s00262-011-1012-8 Boussiotis, 2016, Molecular and biochemical aspects of the PD-1 checkpoint pathway, N Engl J Med, 375, 1767, 10.1056/NEJMra1514296 Ribas, 2012, Tumor immunotherapy directed at PD-1, N Engl J Med, 366, 2517, 10.1056/NEJMe1205943 Seiler, 2017, Impact of molecular subtypes in muscle-invasive bladder cancer on predicting response and survival after neoadjuvant chemotherapy, Eur Urol, 72, 544, 10.1016/j.eururo.2017.03.030 Sharma, 2017, Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial, Lancet Oncol, 18, 312, 10.1016/S1470-2045(17)30065-7 Rosenberg, 2016, Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial, Lancet, 387, 1909, 10.1016/S0140-6736(16)00561-4 Powles, 2014, MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer, Nature, 515, 558, 10.1038/nature13904 Balar, 2017, Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial, Lancet, 389, 67, 10.1016/S0140-6736(16)32455-2 2014, Comprehensive molecular characterization of urothelial bladder carcinoma, Nature, 507, 315, 10.1038/nature12965 2017, Genentech Provides Update on Phase III Study Of TECENTRIQ (Atezolizumab) In People With Previously Treated Advanced Bladder Cancer Bellmunt, 2017, Pembrolizumab as second-line therapy for advanced urothelial carcinoma, N Engl J Med, 376, 1015, 10.1056/NEJMoa1613683 Plimack, 2017, Safety and activity of pembrolizumab in patients with locally advanced or metastatic urothelial cancer (KEYNOTE-012): a non-randomised, open-label, phase 1b study, Lancet Oncol, 18, 212, 10.1016/S1470-2045(17)30007-4 Balar, 2017, Pembrolizumab as first-line therapy in cisplatin-ineligible advanced urothelial cancer: Results from the total KEYNOTE-052 study population, J Clin Oncol, 35, 6, 10.1200/JCO.2017.35.6_suppl.284 Balar AV, Castellano D, O'Donnell PH, Grivas P, Vuky J, Powles T, et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017 Sep 26. pii: S1470-2045(17)30616-2. http://dx.doi.org/10.1016/S1470-2045(17)30616-2. [Epub ahead of print]. Hahn, 2017, Updated efficacy and tolerability of durvalumab in locally advanced or metastatic urothelial carcinoma (UC), J Clin Oncol, 35, 10.1200/JCO.2017.35.15_suppl.4525 Massard, 2016, Safety and efficacy of durvalumab (MEDI4736), an anti-programmed cell death ligand-1 immune checkpoint inhibitor, in patients with advanced urothelial bladder cancer, J Clin Oncol, 34, 3119, 10.1200/JCO.2016.67.9761 Heery, 2017, Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial, Lancet Oncol, 18, 587, 10.1016/S1470-2045(17)30239-5 Apolo, 2017, Updated efficacy and safety of avelumab in metastatic urothelial carcinoma (mUC): Pooled analysis from 2 cohorts of the phase 1b Javelin solid tumor study, J Clin Oncol, 35, 10.1200/JCO.2017.35.15_suppl.4528 Larkin, 2015, Combined nivolumab and ipilimumab or monotherapy in untreated melanoma, N Engl J Med, 373, 23, 10.1056/NEJMoa1504030 Sharma, 2016, Efficacy and safety of nivolumab plus ipilimumab in metastatic urothelial carcinoma: first results from the phase I/II CheckMate 032 study, Journal of Clinical Oncology, 34, 4501, 10.1200/JCO.2016.34.15_suppl.4501 von der Maase, 2000, Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study, J Clin Oncol, 18, 3068, 10.1200/JCO.2000.18.17.3068 Leow, 2014, Adjuvant chemotherapy for invasive bladder cancer: a 2013 updated systematic review and meta-analysis of randomized trials, Eur Urol, 66, 42, 10.1016/j.eururo.2013.08.033 Galsky, 2016, Effectiveness of adjuvant chemotherapy for locally advanced bladder cancer, J Clin Oncol, 34, 825, 10.1200/JCO.2015.64.1076 Sternberg, 2015, Immediate versus deferred chemotherapy after radical cystectomy in patients with pT3-pT4 or N+ M0 urothelial carcinoma of the bladder (EORTC 30994): an intergroup, open-label, randomised phase 3 trial, Lancet Oncol, 16, 76, 10.1016/S1470-2045(14)71160-X Grossman, 2003, Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer, N Engl J Med, 349, 859, 10.1056/NEJMoa022148 Kamat, 2017, BCG-unresponsive non-muscle-invasive bladder cancer: recommendations from the IBCG, Nat Rev Urol, 14, 244, 10.1038/nrurol.2017.16 Smith DC, 2017, Epacadostat plus pembrolizumab in patients with advanced urothelial carcinoma: preliminary phase I/II results of ECHO-202/KEYNOTE-037, J Clin Oncol, 35, 10.1200/JCO.2017.35.15_suppl.4503 McConkey, 2016, Eur Urol, 69, 855, 10.1016/j.eururo.2015.08.034 Rebouissou, 2014, EGFR as a potential therapeutic target for a subset of muscle-invasive bladder cancers presenting a basal-like phenotype, Sci Transl Med, 6, 244ra91, 10.1126/scitranslmed.3008970 Pal, 2016, Efficacy of BGJ398, a fibroblast growth factor receptor (FGFR) 1-3 inhibitor, in patients (pts) with previously treated advanced/metastatic urothelial carcinoma (mUC) with FGFR3 alterations, J Clin Oncol, 34, S4517, 10.1200/JCO.2016.34.15_suppl.4517 Choudhury, 2016, Afatinib activity in platinum-refractory metastatic urothelial carcinoma in patients with ERBB alterations, J Clin Oncol, 34, 2165, 10.1200/JCO.2015.66.3047 Petrylak, 2017, A phase I study of enfortumab vedotin: updated analysis of patients with metastatic urothelial cancer, J Clin Oncol, 35, 10.1200/JCO.2017.35.6_suppl.290